MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: patient pump 2 did not turn when activated.In order to solve the issue, the entire patient pump bridge was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed an error message associated to patient 2 pump blocked or too slow.The issue occurred during procedure.There was no patient injury.

Manufacturer Narrative

H10: based on technical intervention and considering investigation results of previous similar events, the most likely root cause of the reported issue can be associated to pump motor bearing damaged by the corrosion, which consequently does not allow the motor shaft to rotate.Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18569741
• MDR Text Key: 333552256
• Report Number: 9611109-2024-00047
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/30/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1